ISO 11979-5:2020 PDF

Scope: This document specifies particular requirements for the biocompatibility evaluation of materials for intraocular lenses (IOLs) including the processing conditions to produce them. These requirements include evaluation of physicochemical properties that are relevant to biocompatibility. It also gives guidance on conducting an ocular implantation test.

ISO 11979-5:2020 Referenced Document

ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 10993-2 Biological evaluation of medical devices — Part 2: Animal welfare requirements*， 2022-11-03 Update
ISO 10993-3 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
ISO 10993-5 Biological evaluation of medical devices — Part 5: Tests for cytotoxicity: in vitro methods
ISO 10993-6 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
ISO 11979-1 Ophthalmic implants — Intraocular lenses — Part 10: Clinical investigations of intraocular lenses for correction of ametropia in phakic eyes
ISO 11979-2 Ophthalmic implants - Intraocular lenses - Part 2: Optical properties and test methods
ISO 11979-3 Ophthalmic implants - Intraocular lenses - Part 3: Mechanical properties and test methods
ISO 14971 Medical devices - Application of risk management to medical devices
ISO 18369-4 Ophthalmic optics — Contact lenses — Part 4: Physicochemical properties of contact lens materials
ISO/TR 22979 Ophthalmic implants - Intraocular lenses - Guidance on assessment of the need for clinical investigation of intraocular lens design modifications
ISO/TS 21726 Biological evaluation of medical devices — Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents

2020 ISO 11979-5:2020 Ophthalmic implants — Intraocular lenses — Part 5: Biocompatibility
2006 ISO 11979-5:2006 Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility
1999 ISO 11979-5:1999 Ophtalmic implants - Intraocular lenses - Part 5: Biocompatibility